CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 392 enrolled
Drug / intervention
Group 1 +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00375089
NCT00375089N/ACompleted
CompareCT.gov

Prader-Willi Syndrome and Early-onset Morbid Obesity Natural History Clinical Protocol

University of Florida·observational·Posted Sep 12, 2006·Updated Sep 22, 2014

In Brief

An observational study evaluating Group 1 and Group 2 for Prader-Willi Syndrome and Obesity. Completed, enrolled 392 participants across 4 sites.

Detailed Summary

Prader-Willi syndrome (PWS) is a rare genetic disorder that affects about 1 in 14,000 people in the United States. As the most commonly identified genetic cause of obesity, PWS is often confused with Early-onset Morbid Obesity (EMO). Individuals with EMO show some signs of PWS, but clinically do not have PWS. The purpose of this study is to evaluate the clinical features and genetic basis of PWS and EMO, and to determine how these conditions affect a person throughout a lifetime.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsPrader-Willi Syndrome, Obesity
CountriesUnited States
CollaboratorsOffice of Rare Diseases (ORD), Rare Diseases Clinical Research Network, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Timeline

N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 12, 2006
Enrollment StartSep 1, 2006
Primary CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 19.8 years ago

Interventions

Group 1other

Individuals with Prader-Willi syndrome. Monitoring every 6 months.

Group 2other

Individuals with Early-onset Morbid Obesity.